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Prevalence of Osteoporosis and Fractures in Patients With Hepatic Cirrhosis and Investigation of the Associated Factors (POC)

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ClinicalTrials.gov Identifier: NCT03201016
Recruitment Status : Unknown
Verified June 2017 by Jordi Sanchez-Delgado, Corporacion Parc Tauli.
Recruitment status was:  Recruiting
First Posted : June 28, 2017
Last Update Posted : June 28, 2017
Sponsor:
Information provided by (Responsible Party):
Jordi Sanchez-Delgado, Corporacion Parc Tauli

Tracking Information
First Submitted Date May 9, 2017
First Posted Date June 28, 2017
Last Update Posted Date June 28, 2017
Actual Study Start Date June 2016
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 26, 2017)
Assess the prevalence of osteoporosis and fractures in patients with hepatic cirrhosis [ Time Frame: It is a cross-sectional prevalence study. Patients will be recruited for two years. ]
To confirm the presence of osteoporosis and fractures in patients with cirrhosis, the investigators wil perform: - Bone Densitometry measured in standard deviations
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: June 26, 2017)
Assess the associated factors risk of osteoporosis and fractures [ Time Frame: It is a cross-sectional prevalence study. Patients will be recruited for two years. ]
Factors that will be studied: • Data regarding cirrhosis (etiology; alcohol/hepatitis C virus, both of them)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 26, 2017)
Assess the prevalence of osteoporosis and fractures using trabecular bone score [ Time Frame: It is a cross- sectional prevalence study. Patients will be recruited for two years. ]
The TBS (Trabecular Bone Score) is derived from the evaluation of the experimental variogram, obtained from the grayscale of the bone densitometry. This score may be more sensitive to detect osteoporosis.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Prevalence of Osteoporosis and Fractures in Patients With Hepatic Cirrhosis and Investigation of the Associated Factors
Official Title Prevalence of Osteoporosis and Fractures in Patients With Hepatic Cirrhosis and Investigation of the Associated Factors
Brief Summary

Osteoporosis is a common complication in chronic liver disease, especially in the late stages of the disease. Good nutrition and calcium and vitamin D supplementation are recommended for the prevention and treatment of osteoporosis. There are no specific guidelines for its pharmacological treatment, but bisphosphonates have been shown to be effective in increasing bone mass in patients with chronic cholestasis, with a good safety profile.

There are few studies evaluating the prevalence of osteoporosis in patients with cirrhosis (except for primary biliary cholangitis (PBC)). There are no clear recommendations for osteoporosis screening in cirrhotic patients. A diagnosis and early therapeutic intervention before the onset of the complications derived would significantly improve the quality of life and decrease the morbidity and mortality associated with osteoporosis and fractures

Objective:

-To assess the prevalence of osteoporosis and fragility fractures in patients with liver cirrhosis in our country and the risk factors associated

Method:

Patients diagnosed with hepatic cirrhosis, other than PBC, will be included in any Child stage during a hospital admission. Epidemiological, demographic, clinical, analytical and imaging data (dorso-lumbar spine radiography, bone densitometry and Trabecular Bone Score) will be evaluated. A descriptive statistic of the main variables will be carried out as well as a multivariate analysis to evaluate the predictive factors of osteoporosis and / or fragility fractures

Detailed Description

Osteoporosis is a common complication in chronic liver disease, especially in the late stages of the disease. The main mechanism involved in the development of osteoporosis in patients with cirrhosis is the deficit of bone formation due to the harmful effect of substances such as bilirubin and bile acids or the toxic effect of alcohol or iron on osteoblasts .

Good nutrition and calcium and vitamin D supplementation are recommended for the prevention and treatment of osteoporosis. There are no specific guidelines for its pharmacological treatment, but bisphosphonates have been shown to be effective in increasing bone mass in patients with chronic cholestasis, with a good safety profile.

Hospital admissions in relation to osteoporotic fractures in cirrhotic patients are frequent with a high morbidity and mortality rate. There are few studies evaluating the prevalence of osteoporosis in patients with cirrhosis with a different etiology from PBC and the existing series are published years ago with few patient numbers. There are no clear recommendations for osteoporosis screening in cirrhotic patients. A diagnosis and early therapeutic intervention before the onset of the complications derived would significantly improve the quality of life and decrease the morbidity and mortality associated with osteoporosis and fractures

Objective:

  • To assess the prevalence of osteoporosis and fragility fractures in patients with liver cirrhosis in our country.
  • To assess the risk factors associated with osteoporosis and fractures in these patients.

Method:

Patients diagnosed with hepatic cirrhosis, other than PBC, will be included in any Child stage during a hospital admission. Epidemiological, demographic, clinical, analytical and imaging data (dorso-lumbar spine radiography, bone densitometry and Trabecular Bone Score) will be evaluated. Additional visits to those already carried out in normal practice will not be necessary. A descriptive statistic of the main variables will be carried out as well as a multivariate analysis to evaluate the predictive factors of osteoporosis and / or fragility fractures

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 6 Months
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with hepatic cirrhosis due to hepatitis C virus or alcohol, decompensated or not decompensated and who follow controls in our hospital
Condition Osteoporosis
Intervention Diagnostic Test: Bone densitometry
Procollagen Type I Propeptides, alkaline phosphatase, Crosslinked Telopeptides of Type I Collagen
Other Name: Trabecular Bone Score
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: June 26, 2017)
110
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2018
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Give informed consent to participate in the study
  • Hepatic cirrhosis diagnosed by histological criteria or clinical, analytical and ultrasound criteria
  • Age over 18 years

Exclusion Criteria:

  • Ascitic decompensation (estimated ascitic fluid> 4 liters) at the time of bone densitometry
  • Patients bedridden or with very bad mobility, that makes the displacement complicated
  • Terminal illness with estimated life expectancy less than one year due to hepatic impairment or tumor disease
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT03201016
Other Study ID Numbers 2015540
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Jordi Sanchez-Delgado, Corporacion Parc Tauli
Study Sponsor Corporacion Parc Tauli
Collaborators Not Provided
Investigators
Principal Investigator: Jordi Sánchez-Delgado, M.D. PhD Unitat de Malalties Digestives, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí I3PT
PRS Account Corporacion Parc Tauli
Verification Date June 2017